- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00780247
Environmental Influences on Vitamin D Status (Alaska/Hawaii)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Purpose of the study: To determine the effect of environmental influences on Vitamin D status.
Specific Aims
- To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes (Alaska and Hawaii).
- To collect information on variables that influence Vitamin D status such as skin color, history of sun exposure and sunscreen use, diet history, vitamin and calcium supplements used, and BMI.
- To collect typical food samples from the region for future analysis of their Vitamin D and 25D content.
- To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D metabolism (Gc or Vitamin D binding protein alleles).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Kidney and Diabetes Associates
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Age of Subjects: The subjects will be between ages 18-60. The upper age is limited to age 60 as aging skin is less able to make vitamin D, therefore a separate study of elderly people would be more appropriate.
Racial and Ethnic Origin: Both sites have a diverse ethnic and racial population and the subjects will be as representative of the population as possible.
Beskrivelse
Inclusion Criteria:
- Able to consent and come for a study visit. Male or female males and females ages 18-60.
Exclusion Criteria:
- Unable to consent or come to a visit, taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Alaska residents
50 "healthy" community dwelling males or females.
|
|
Hawaiian residents
50 "healthy" community dwelling males or females at each site
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes
Tidsramme: crosssectional
|
crosssectional
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
2. To collect information on variables that influence Vitamin D status such to collect information on skin color, history of sun exposure and sunscreen use, diet history, vitamin and calcium supplements used, and BMI.
Tidsramme: cross sectional
|
cross sectional
|
|
To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D metabolism (Gc or Vitamin D binding protein alleles).
Tidsramme: cross sectional
|
cross sectional
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Laura A Armas, MD, Creighton University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Creighton6
- WIRB approval 20080712
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